Clinical Trial

4-electrode ECG (DigitalCardio®) vs Standard 10-electrode ECG: Evaluating Ease of Use and Recording Quality

Study acronym: FAST-ECG
Not Yet Recruiting
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Summary
The goal of this clinical trial is to compare the time required to record a complete Electrocardiogram (ECG) trace using the DigitalCardio (CardioSecur®) tablet device versus a standard 12-lead ECG device in eligible patients. The main questions it aims to answer are: Is there a difference in diagnostic recording time (in minutes) between the DigitalCardio tablet and a standard ECG machine? How do the two devices compare in terms of trace quality (including QRS duration, QT interval, frontal axis measurements, and missing/erroneous leads)? How satisfied are healthcare professionals with the CardioSecur® device? Researchers will compare Group A (standard 10-electrode ECG followed by 4-electrode ECG) to Group B (4-electrode ECG followed by standard 10-electrode ECG) in a 1:1 randomized crossover design to evaluate recording efficiency and trace quality. Participants will: Complete an initial screening visit with the principal investigator to review eligibility criteria and sign the informed consent form. Be randomly assigned (1:1 ratio) to either Group A or Group B. Undergo both ECG recording methods sequentially (a standard 10-electrode ECG and a 4-electrode ECG using the DigitalCardio tablet), while researchers measure the total time elapsed from electrode placement to obtaining a complete trace.
Trial Details
NCT Number NCT07732283
Lead Sponsor Clinique Bizet
Conditions 4-electrode Tablet-based Electrocardiogram (ECG) System, Electrical Activity of the Heart, Atrial or Ventricular Arrhythmias, Intracardiac Conduction Abnormalities, QT Interval Prolongation, Myocardial Ischemia, Ventricular Hypertrophy, Tandard 12-lead (10-electrode) ECG Device
Enrollment 50 participants
Start Date 2026-06
Primary Completion 2026-12 (estimated)
Study Completion 2027-03 (estimated)
Updated on ClinicalTrials.gov 2026-07-29